BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X)

    MDR report key: 15594877 · Received October 13, 2022

    Report

    Report Number
    3005180920-2022-00779
    Event Type
    Injury
    Date Received
    October 13, 2022
    Date of Event
    September 22, 2022
    Report Date
    November 8, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630040716086
    PMA / PMN Number
    K171758
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW NOT PERFORMED SINCE LOT IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT. MOBILIZATION OF SET SCREW IN A 2 LEVEL LUMBAR STABILIZATION TREATMENT 3 MONTHS AFTER SURGERY. EXPLANTS WERE NOT RETURNED, THEREFORE NO TECHNICAL EXAMINATION COULD BE RUN. THE MOST PROBABLE CAUSE IS INSUFFICIENT TIGHTENING TORQUE. SOMETIMES THE SURGEONS IS AFRAID OF CREATING DAMAGES TO THE BONE OR SURROUNDING TISSUES BY EXCESSIVE TIGHTENING. A FINAL CONCLUSION CANNOT BE DRAWN WITH THE ELEMENTS AT HAND. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER. DURING THE VISUAL INSPECTION, IT HAS BEEN PERFORMED THE ANALYSIS OF THE MUST COMBINED SETSCREW, REF. 03.50.204, LOT: 2221847. THE DEVICE IS ACCORDING TO THE SPECIFICATION FOR THE DIMENSIONAL AND FUNCTIONAL POINT OF VIEW. NO NCS ARE ASSOCIATED TO THE LOT. A FUNCTIONAL TEST HAS BEEN PERFORMED WITH THE DEVICE ON A BRAND NEW PEDICLE SCREW WITH POSITIVE RESULTS. BATCH REVIEW PERFORMED ON 19-OCT-2022. LOT: 2221847: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-MAR-2022. EXPIRATION DATE: 2027-03-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    LOOSENING OF THE SETSCREW 3 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON EXPECTS THAT THERE WAS NOT DUE TO AN IMPLANT FAILURE RATHER A PERSONAL ERROR. THE SETSCREW WAS CHANGED AND PROPERLY FIXED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2567160 PEDICLE SCREW MUST COMBINED SETSCREW H4-T27 - (4X) SPINE PEDICLE SCREW SET SCREW NKB MEDACTA INTERNATIONAL SA 03.50.206 2221847 07630040716086

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention